The study is a multicenter, open-label, dose-escalation and expansion phase Ⅰ/Ⅱ clinical study. The phase Ⅰ part aims to evaluate the safety, tolerability, and pharmacokinetics of LBL-033 for the treatment of subjects with advanced malignancies, and to provide recommended doses for subsequent clinical studies. The primary objective of the Phase Ⅱ part is to evaluate the efficacy of LBL-033.
"I am pleased to see that the FDA has quickly approved the clinical trial application of LBL-033 in the United States, and I am grateful for the good suggestions given by the FDA during the IND review process. These have laid a good foundation for the rapid, high-quality and effective development of this new targeted immunotherapy." said
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, "
LBL-033 adopts a unique bispecific antibody molecule design to allow better drug aggregation in MUC16-overexpressing tumorMUC16-overexpressing tumor cells and to reduce the non-specific activation of CD3, which may help improve efficacy and reduce side effects such as cytokine release syndrome. We look forward to the clinical evaluation of the safety and efficacy of this innovative drug in order to bring it to the general population of cancer patients as soon as possible."
Ovarian cancer is the second most prevalent gynecologic malignancy in developed countries and the first of the three major gynecologic malignancies in terms of mortality, posing a serious threat to women's health. 314,000 new cases were diagnosed worldwide in 2020 and about 207,000 women died from the disease, with a rising trend year by year. Epithelial carcinoma is the most common type, accounting for about 80-90% of ovarian malignancies. Epithelial ovarian cancer frequently occurs in women aged 50-70 years. Currently, there is no effective and sufficiently accurate screening procedure to detect early-stage ovarian cancer. First-line platinum/paclitaxel-based chemotherapy is the standard of care for advanced ovarian cancer, with an efficiency rate of more than 80%. 5-year survival rate is 40-50%, and the survival rate for intermediate and advanced stages is approximately 30%. However, recurrence still occurs in 50-70% of patients. For patients with recurrent disease, treatment aims mainly to reduce symptoms and improve patients' quality of life. Therefore, there is a need to develop more effective treatment modalities to reduce the relapse rate and prolong the relapse-free interval.
LBL-033 is the first bispecific antibody targeting MUC16/CD3 that has been approved for clinical trial in China.
Nanjing Leads Biolabs Co., Ltd. is a clinical-stage R&D biotech company founded in Nanjing by a team of senior U.S.-educated antibody drug developers. Since 2014, Leads Biolabs has been dedicated to the research and development of novel antibody drugs with independent intellectual property rights for the treatment of oncology and other major diseases, mainly focused on the unmet pharmaceutical needs, especially the problems and challenges in tumor immunotherapy areas. Leads Biolabs already have a rich R&D pipeline with more than twenty novel tumor immunotherapy antibody projects based on monoclonal antibody and bispecific antibody development technology platform. Leads Biolabs will continue to expand its innovation to provide patients with safe, effective, accessible and affordable new drugs to meet the unmet pharmaceutical needs.
For more information, please visit: https://www.leadsbiolabs.com
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